Safety Information

CBER Recalls / Withdrawals | FDA MedWatch | FDA Patient Safety News | FDA's Sentinel Initiative

2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999

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2008

Information from CDC and FDA on the Safety of Gardasil Vaccine - 7/22/2008

Pregnancy and Lactation Labeling - 5/28/2008

FDA's Sentinel Initiative - 5/22/2008

Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product - 4/17/2008

Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTANT S/D Packaged in 2-ml Syringes - 3/5/2008

What Clinicians Need to Know About MMRV Vaccine Safety - CDC - 2/27/2008

Important Safety Information: Dosing and Administration of Rabies Immune Globulin (Human), HyperRAB™ S/D Packaged in 2-ml Syringes - 2/22/2008

2007

Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB® and Comvax®) - MMWR - 12/19/2007

PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - Voluntary Recall - MedWatch - 12/14/2007

FDA Statement on Gene Therapy Clinical Trial - 7/26/2007

Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products - 3/15/2007

FDA Preliminary Public Health Notification*: Unpredictable Events in Medical Equipment due to New Daylight Savings Time Change - 3/1/2007

Advice for Patients: Change in Daylight Savings Time May Affect Your Medical Equipment in an Unpredictable Way - 3/1/2007

FDA Public Health Notification: Information on RotaTeq and Intussusception - 2/13/2007

Postmarketing Monitoring of Intussusception After RotaTeq Vaccination --- United States, February 1, 2006--February 15, 2007 (MMWR) - 3/16/2007

2006

Statement - FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome - 10/20/2006

Update: Guillain-Barré Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006 - MMWR - 10/20/2006

FEDERAL REGISTER - Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form - 10/20/2006; Expires May 1, 2007

FDA Public Health Notification: Donor Referral Services - 8/30/2006

FDA Public Health Notification: Update of Information about BioMedical Tissue Services - 3/2/2006

Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006 - MMWR - 5/26/2006

Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF) - Revisions to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information to address two important safety concerns - MedWatch - 1/6/2006

2005

Important Safety Alert: BacT/ALERT BacT/VIEW Users - Database corruption situation that may lead to a failure to report positive cultures or cause a delay in appropriate patient therapy - (Biomerieux) - 12/16/2005

NovoSeven Coagulation Factor VIIa (Recombinant) - Potential increased risk of thromboembolic adverse events - (Novo Nordisk) - 12/1/2005

Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products - 11/9/2005

Guillain-Barré Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine - United States, June-July 2005 - MMWR - 10/6/2005

FDA and CDC Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome - FDA News - 9/30/2005

DIC following Rho(D) Immune Globulin Intravenous Administration - Abstract - 9/1/2005

Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hemoglobinuria following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura - Gaines, Ann R., Blood, Vol 106, No 5 - 9/1/2005

Safety of Albumin Administration in Critically Ill Patients - 5/16/2005

Dear Doctor Letter - Albumin Use in Seriously Ill Patients - 8/19/1998

Unapproved Home-Use Diagnostic Kits Marketed by Globus Media - Medwatch - 2/7/2005

Recall of Rapid HIV Test Kits - (Globus Media Inc) - 2/4/2005
FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper - 2/7/2005

Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/19/2005

Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/8/2005

2004

Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter (Update) - Pall Medical Corp - 12/17/2004

Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter - Pall Medical Corp - 12/10/2004

Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg) - Abbott Diagnostics, Becton Dickinson - 11/18/2004

Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System - Gambro BCT, Inc - 7/23/2004

Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine - MMWR - 4/2/2004

2003

Antibody to HBsAg ELISA Test System 3 (Ortho-Clinical Diagnostics Inc) - Increased reactive rate and false repeat reactive rate - MedWatch - 12/23/2003

Update on Particulate Matter in Blood Bags - 10/31/2003

FDA Announces Initiative to Heighten Battle Against Counterfeit Drugs - 7/16/2003

Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry --- United States, 2003 - MMWR - 5/2/2003

FDA Current Thinking on Irradiating and/or Freezing Blood Components Collected and Stored in Anticoagulant/Preservative Solutions Not Specifically Approved for Such Use - 3/5/2003

Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood - 2/27/2003

Update on FDA's Continuing Investigation of Particulate Matter in Blood Shows Normal Blood Components and No Evidence for an Increase in Adverse Events - 2/27/2003

Information Alert on Particulate Matter in Blood Bags - 2/7/2003

FDA Recommends Temporary Additional Blood Inspection Measures as it Continues Investigation of Reports of White Particulate Matter in Some Units of Blood and Blood Components - 2/7/2003

2002

Public Health Dispatch: Investigation of Blood Transfusion Recipients with West Nile Virus Infections - MMWR - 9/13/2002

CDC Investigates Possible West Nile Virus Transmission Through Organ Transplant - Press Release - 9/1/2002

Information about West Nile Virus and Blood Safety - 8/17/2002

FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV) - 8/27/2002

CDRH - Public Health Notification: Human Tissue Processed by Cryolife, Inc. - 8/21/2002 (PDF), (Text)

FDA Issues Order to Recall and To Prevent Further Use of Human Tissue Processed at Cryolife, Inc. - 8/14/2002

FDA Public Notification: PVC Devices Containing the Plasticizer DEHP - Blood bags and infusion tubing may contain DEHP-plasticized PVC - MedWatch - 7/12/2002

Important New Drug Warning - PLAS+SD (Pooled Plasma), (Human) Solvent Detergent Treated) - 3/29/2002

Immune Globulin Intravenous (Human) - Baxter Healthcare Corp - Serious thrombotic events
Post marketing reports describing serious thrombotic events (vascular occlusion) possibly associated with the administration of Immune Globulin Intravenous (Human) (IGIV). Precautionary statements, advising physicians to exercise caution in administering IGIV to patients with cardiovascular disease or previous thrombotic events, have been added to the labeling of both Baxter's Gammagard S/D and American Red Cross' Polygam S/D. The letters remind healthcare professionals of measures that may be important in reducing the risk of a thrombotic event. - MedWatch - 3/26/2002

Important Recall Information Relating to Immune Globulin Intravenous (Human) - (Bayer Corp) - 3/20/2002, Updated 3/21/2002

Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N - (Bayer Corp) - 3/14/2002
Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N - (Bayer Corp) - 2/1/2002

Lymphocyte Immune Therapy (LIT) Letter - 1/30/2002 - (Text), (PDF)
Note: the correct CBER contact telephone number is 301-827-5102

Updated -Transfusion Related Acute Lung Injury Letter - 10/19/2001 - (Text), (PDF)

2001

2000

PLAS+SD (Pooled Plasma, [Human] Solvent Detergent Treated), Important Prescribing Information - MedWatch - 10/20/2000

Murex SUDS HIV-1 (Rapid EIA), Abbott Laboratories, Manufacturing problems related to the failure to meet certain panel and negative control specifications - MedWatch - 10/18/2000

Availability of Abbott / Murex Single Use Diagnostic System (SUDS) HIV-1 Test - 10/18/2000

FDA considers the risk of bacteremia from Red Blood Cell units using Pre-storage Leukocyte Reduction Set for Red Cells filters (Sepacell) to be very low - 9/22/2000

Autologous Cultured Chondrocytes (Carticel), Genzyme Tissue Repair - Notice of Change in Product Labeling - MedWatch - 3/16/2000

Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays - CDRH Letter - 3/29/2000
Clinipad Recall Further Information - MedWatch - 3/10/2000
FDA Alerts Health Professionals and Consumers to Nationwide Recall of Clinipad Antiseptic Sterile Products - HHS NEWS - 3/10/2000
Recall of Sterile Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, and Alcohol Antiseptic Products as Well as Sterile Cliniguard® Protective Dressing, and Specified Lots of Nonsterile Products - 3/9/2000

Poliovirus Vaccine Live Oral Trivalent (Orimune) - Change in storage conditions - MedWatch - 2/7/2000

Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF) - Updated prescribing and treatment information: Rho(D) positive patients treated with WinRho SDF should be monitored for signs and/or symptoms of intravascular hemolysis (IVH), clinically compromising anemia, and renal insufficiency - MedWatch - 1/7/2000

1999

Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human) - 9/24/1999 - (PDF), (Text)

Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service - 7/9/1999 (use MMWR search for "thimerosal")

False Negative Results With Use of Unapproved HIV Rapid Home-Use Test Kit - EZ MedTest - 7/6/1999

URGENT BIOLOGIC FIELD CORRECTION of Immune Globulin Intravenous (Human) - 7/1/1999

URGENT REQUEST for Product QUARANTINE of Immune Globulin Intravenous (Human), Alpha Therapeutic Corp. - 6/11/1999

Immune Globulin Intravenous (Human) - Associated renal adverse events - Medwatch - 6/25/1999

Albumin (Human) 25% - Medwatch - 3/5/1999

Immune Globulin Intravenous (Human) - Medwatch - 3/5/1999